OTC provides Study Facilitators who guide investigators and study personnel through the clinical research process, from study idea and design through close-out and publication, for clinical and translational research projects.

Study Facilitators are health professionals with extensive clinical research experience and expertise in navigating the Stanford clinical and translational research system. A Study Facilitator will advise you and consult appropriate experts regarding:

Getting Started

Do I need help with my study design?

What is a Case Report Form and how do I create one?

Can I do my study at Stanford?

What resources are available to support my project?

Regulatory Requirements

What are FDA requirements?

Do I need IRB approval?

Do I need an IND or IDE for my research project?

What does it mean to be a Sponsor-Investigator?

What documents are essential for my research?

Budget and Billing Matters

What is RMG and who is my RPM?

What is Medicare Pre-authorization?

How do I get started with my budget?

Who do I contact for billing issues?

What is the workbook?

Staffing Needs

Do I need a coordinator?

What does a coordinator do?

How much will a coordinator cost?

Grant and Contract Processes

When do I need a contract?

What is the Office of Sponsored Research (OSR) and who is my contract officer?

How do I finance my study?

Do I need a contract if I am getting equipment on loan?

Who do I contact about my grant?

Next Steps

Spectrum Pilot Grants

Spectrum provides pilot funding to support clinical and translational research in a number of areas, with opportunities to apply for funding every one to two years. Pilot grants are administered by Spectrum under the guidance of Biodesign (medical devices), SPARK (drugs and diagnostics), Population Sciences, and the Office of Community Health (Academic-Community partnerships).

Spectrum Administrative Supplements

Occassionally NIH funds Administrative Supplements to the parent grant that supports Spectrum. Currently open or recently funded opportunities are posted below.

CTSA Administrative Supplement Funding Opportunity #1
(recently funded)
Supplements to support new or ongoing bench-to-bedside T1-type research (collaboration between faculty at two or more CTSA sites) (up to $500,000 total costs for 1 year)

Stanford Center for Clinical Informatics (SCCI) consultants will help review your project's data management and informatics needs and assist with developing a budget and Informatics/IT support proposal section for your grant prior to submission.

Stanford Cancer Institute Research Database (SCIRDB) personnel work with you to plan for your needs related to cancer projects. The ideal engagement occurs when either you are formulating the project or writing the grant application. The planning phase involves:

Determining the duration and requirements of the project

Determining how the investigators would interact with project data

Estimating the resources (hardware, software, and personnel) needed for a project

Charting a timeline for execution of the deliverables with specified milestones

An essential step in clinical research, after you've secured funding and established the parameters of your project, is organizing a staff that will enable you to conduct the study. If you're already working in a clinical setting, you'll most likely have a staff of health care professionals and administrators to assist you with patients. However, if you don't have access to these resources, you'll need to carefully consider your staffing needs. The first step is to determine the type of staff you need.

For many clinical studies, having an RN on staff is essential because you'll need someone with a solid health care background who can perform some medical procedures. If your research project involves an experimental drug or medical device, you'll need someone who can watch for possible adverse events and who is knowledgeable about the risks and benefits to the study participants. You'll also need someone who can communicate effectively with participants and be able to explain or discuss the nature of the study with someone who doesn't have a medical background.

In some cases, a licensed practical nurse, someone with medical training, or someone with research experience might suffice, but to independently monitor and assess study participants, you'll need a research nurse.

Do you need a research coordinator or data manager?

A research coordinator or a data manager can be very helpful additions to your staff. While a data manager can assist in maintaining data records and ensuring continuity in data collection, a research coordinator can provide valuable assistance in recruiting and screening study participants or in carrying out certain elements of the research project. Research coordinators can also help with management of the Regulatory Binder and consenting of patients for less medically complex protocols. Some research coordinators have phlebotomy certificates which allows them to help with blood draws if needed.

Are there special staffing considerations for a very large project?

If you're conducting a large clinical research project or find yourself in an especially large clinical setting, you might want to hire staff members specifically to handle regulatory work and clinical coordination. Ensuring that your study is compliant with FDA regulations throughout the project and that IRB submissions are handled properly and on-time can be demanding, especially in the case of a large study; having a person designated to handle such tasks can be a major benefit. This may mean you need a research nurse, a research coordinator and a data manager.

Decision tree to help investigators in hiring research staff

Investigators are responsible for protecting the rights, safety, and welfare of subjects under their care during a clinical trial (21 CFR 312.60 and 812.100).

The following skills are necessary to help you with your protocol management depending on the complexity of your research protocol and subjects. These will ensure that your study is managed effectively with emphasis on the safety and follow up of your subjects as well as managing the protocol to the highest standard per ICH and GCP guidelines.

Critical Decision Skills

Protocol Management

Subject Safety

AE management

Knowledge Base

Recruitment

Consenting

Education

Assessment

Screening

AE management

Subject follow up

Extraction and Analyzation and Interpretation of Information/Data

AE reporting

Management of abnormal values, etc.

Source documentation and CRF completion

To help you determine what experience and training your coordinator should have, it is important that you have an understanding of the protocol. The following subject headings will provide you with some guidance to determine the level of complexity that is required based on your subject population and what is being studied.

Will the protocol require other health care providers to receive education/in-service?

Will the subject require subject education for compliance of protocol

Same list as above under Coordination

Resources for Finding a Coordinator

Spectrum has an email list of experienced university staff interested in part-time and full-time work. If you have a job posting that you would like us to distribute to our email list please contact Spectrum OTC.

Spectrum periodically circulates information about new openings in clinical research to a self-identified pool of external job-seekers, as well as to our internal research coordinator pool. From time to time, Spectrum is contacted by faculty and department administrators to distribute open clinical research employment opportunities to our database.

Subscribe to the Spectrum OTC email list

If you would like to be added to our e-mail list, please send your information to: Spectrum OTC This is an informal service, intended only to be a supplement to the official University job posting process through the Stanford University Human Resources Office.

Next Steps

No matter what type of human-subject research investigators may be working on, there are some steps that all should take to enhance patient recruitment. By posting studies on the following four websites, researchers can efficiently find the participants needed to complete projects in a timely fashion.

Researchers may post any human-subject study to ClinicalTrials.gov — even observational studies — to benefit from a megaphone of publicity, all underwritten by the National Institutes of Health. ClinicalTrials.gov receives 50 million unique visitors a month, and its clinical trial data is regularly fed onto the Stanford Clinical Trials Directory, patient advocacy websites and the World Health Organization’s trials database, among others. The NIH has recently put more marketing muscle behind this database with the launch of a new website — www.cc.nih.gov/ — to promote clinical trial participation. (Remember that a certain class of interventional studies is required to be listed on ClinicalTrials.gov, and investigators must post these study results on the NIH site within a year after study completion.)

Who is required to register a clinical trial with ClinicalTrials.gov?

A Principal Investigator who holds the IND, IDE or NSR determination for a device.

The Principal Investigator of an investigator-initiated clinical interventional study of drugs (Phases 2-4), biologics or devices, conducted at least in one site in the U.S., excluding multi-site studies where the Stanford PI is a subcontract recipient.

For ICMJE journal publications, the Principal Investigator of an interventional study of any type, phase, or location.

The Stanford Principal Investigator of an NIH-funded clinical intervention study of drugs (Phases 2-4), biologics or devices is responsible for registering the study (the subcontract PI is not responsible). For more information about this requirement, see http://grants.nih.gov/ClinicalTrials_fdaaa

Failure to register with ClinicalTrials.gov

May result in fines from NIH or FDA

May prevent study publication

How to register

Register your clinical trial with ClinicalTrials.gov via a web-based data entry system called the Protocol Registration System (PRS).

When you post your studies to ClinicalTrials.gov, your trials data is automatically downloaded to the Stanford Clinical Trials Directory each night. (Previously, researchers had to manually enter this data into the directory.)

Before a trial is posted to the public-view directory, the trials tool sends a notification to the lead investigator’s CAP (Community Academic Profile) inbox, in the same way that PubMed article notifications occur. At this time the researcher must approve and, if necessary, edit the imported trial description. If an investigator “accepts” a trial, it appears in both the Stanford Clinical Trials Directory and his or her public-view CAP academic webpage. In addition, researchers can manually add Stanford contact information for multicenter trials listings.

ResearchMatch is an NIH-funded resource that connects people who are trying to find research studies with researchers looking for study participants. This free matchmaking service is available for no charge to Stanford researchers because of its membership in the NIH’s Clinical and Translational Science Award consortium. For help with ResearchMatch, contact Peg Tsao, RN

Should you register your research project with ClinicalTrials.gov?

1. YES, if you want your study listed in the Stanford Clinical Trials Directory and on your CAP profile.

If you want your study to appear in the Stanford Clinical Trials Directory (v.2) then you must register your study at the NIH website, ClinicalTrials.gov. Stanford’s CT Directory only displays studies that it can pull from ClinicalTrials.gov.

2. YES, if you want to publish the results of your study.

If you wish to publish your study in a peer-reviewed journal, then it is highly likely that that journal will expect your study to have been registered with ClinicalTrials.gov. Over 1,000 journals have adopted the policy of the International Committee of Medical Journal Editors (ICMJE) that requires registration in a publically available register. The list of journals is at this link: http://www.icmje.org/journals.html

ICMJE requires registration for a wider range of studies than what we traditionally think of as “clinical trials” at Stanford. Here is their definition. Please note that almost any prospective study of medical or health interventions in human beings qualifies, including “observational” research. http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/

“The ICMJE believes that it is important to foster a comprehensive, publicly available database of clinical trials. The ICMJE defines a clinical trial as any research project that prospectively assigns human subjects to intervention or concurrent comparison or control groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Medical interventions include drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like.”

The ICMJE does not require posting of results for studies that are not otherwise required by law to do so.

3. YES, because in some cases, IT’S THE LAW.

A smaller subset of studies are required by law to be registered with ClinicalTrials.gov. The FDA Amendments Act of 2007 (FDAAA) required that most prospective studies involving regulated drugs, biological products, and medical devices must be registered on ClinicalTrials.gov. The law also requires reporting of “basic results” and adverse events for a subset of these studies. If you would like to determine if your study is required by FDAAA to be registered, you can follow the flowchart at this link http://grants.nih.gov/ClinicalTrials_fdaaa/docs/Flow_chart-ACT_only.pdf or contact Spectrum or CCTO for assistance.

4. When do I have to register my study?

ICMJE requires that you register prior to enrollment of your first study participant.

The law requires that a study be registered within 21 days of enrollment of the first participant. You must also update your ClinicalTrials.govrecords at least every 12 months, or within 30 days of a change in recruitment status.

5. When do I have to post basic results?

The law requires that a subset of basic information be posted on ClinicalTrials.gov for any study in which the study product is approved for any use. For example, if you are studying an approved drug for a new use, you must register basic results. You must post this information within 12 months of the “Primary Completion Date” – defined by ClinicalTrials.gov as the final data collection point for the primary endpoint. Please note that you may not wait until complete data analysis of your project is completed to post basic results, if such completion falls outside the required time frame.

6. What are the consequences if I don’t register?

The consequences for non-compliance can include rejection for publication in top journals (even for studies not required by law to register), fines from FDA or NIH, or the withholding of grant funds — for you individually or for the entire institution.

The U.S. Food and Drug Administration website provides information for regulated industry on determining how to comply with the federal laws and regulations governing medical devices. See their Device Advice: Device Regulation and Guidance page for the following information and more:

Overview of Medical Device Regulation

Compliance Activities (Medical Devices)

Postmarket Requirements

Standards

Training

Spectrum works in collaboration with the IRB and the Cancer Clinical Trials Office to provide education and training for investigators and research teams conducting research with INDs and IDEs held by a Stanford investigator.

The U.S. Food and Drug Administration website provides information for the Investigational New Drug (IND) Application. The site includes information and resources including:

Pre-IND Consultation Program

Guidance Documents for INDs

Laws, Regulations, Policies and Procedures

Emergency Use of an Investigational Drug or Biologic

Related Resources, including Applications

Training

Spectrum works in collaboration with the IRB and the Cancer Clinical Trials Office to provide education and training for investigators and research teams conducting research with INDs and IDEs held by a Stanford investigator.

Spectrum mentoring efforts are intended to support the career development of junior investigators and other trainees.

Spectrum Child Health has a well-developed mentoring program for child health investigators. Additional efforts are in early development stages, and ultimately will include a Council of Mentors for junior investigators.

Spectrum OTC provides education, required training and professional growth opportunities to the Stanford clinical research community.

Whether new to Stanford or in need of a refresher course, the below list of training programs provides the information necessary to successfully conduct clinical research at Stanford.

REQUIRED TRAINING FOR CLINICAL RESEARCH PERSONNEL

Collaborative IRB Training Initiative (CITI)* (Required)
Required human subjects training for all staff who work on research projects (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting). More »

Orientation to Clinical Research at Stanford (General Orientation)
Required for new employees who are working in clinical research. At this orientation Spectrum OTC staff will meet with clinical research personnel to provide resources and tools to successfully navigate research studies at Stanford. More »

Budgeting and Billing Training
Required for all new and current employees who work on clinical research projects, if involved in budgeting and billing. Spectrum OTC offers monthly training sessions. More »

Environmental Health and Safety Training AssessmentEveryone in the Stanford community is required to take some safety training. To clarify what safety training is necessary for each job function, Environmental Health and Safety developed the Training Assessment online tool for determining what safety training a SU employee needs to take. More »

HIPAA Training
Stanford HIPAA training is required for every member of the workforce who comes into contact with Protected Health Information (PHI). More »

RECOMMENDED TRAINING

eProtocol TrainingeProtocol is an online application used at Stanford to submit, review, and approve research (human subjects; stem cells; animal subjects; and biosafety). More »

GCP Training through CITI
If you are new to research or just need a refresher course, Good Clinical Practice (GCP) guidelines are available on-line through the IRB’s CITI training. More »

EDUCATION / WORKSHOPS

Find a Workshop
View upcoming CTR educational workshops offered by Spectrum and affiliates, past presentations and videos, a list of courses, or request a workshop. More »

Request a Workshop
View list of workshop topics, or suggest a topic. More »

Epic Training
Epic Training is required for all Stanford Hospital and Clinics physicians and medical personnel who need access to Hospital Medical Records.
Training is completed online. The specific courses that you are required to complete are dependent on your specialty, sub-specialty and scope of clinical practice. More »

Cardinal Curriculum
Cardinal Curriculum is designed to develop Stanford's research administration workforce by providing tools for individuals to build competencies, increase efficiency, and improve compliance with Stanford and sponsor requirements. Training classes, which can lead to certification, are organized into two levels and are geared to individuals as they develop from novice to expert in research administration.
These classes will benefit research administrators and all administrative staff who support sponsored research.
More »

Cancer Clinical Trials Office (CCTO)The CCTO provides training and quality assurance programs for both new and existing research staff to ensure that Cancer Institute research staff are current on all regulatory requirements as well as SCI standard operating procedures. More »

Tech Training
Stanford University Information Technology Services (ITS) provides technology courses. See the ITS website for training options in the classroom, online, one-on-one by appointment, and custom classes. More »

STARS
The Stanford Training And Registration System (STARS) is Stanford's Learning Management System. Log in to Axess to see the STARS Training website which includes a “STARS Browse Catalog” and a “Training Needs Assessment” tool. More »

Learning and Organizational Effectiveness
LOE Calendar of Course, Programs, and Conferences. More »

Office of Sponsored Research (OSR)
The OSR website provides a list of recommended classes for those working with sponsored research. More »

PROFESSIONAL DEVELOPMENT RESOURCES – NON-STANFORD

ACRP
ACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings. More »

University of California Santa Cruz, Extension
The UCSC Extension Certificate in Clinical Trials Design and Management is designed to help professionals gain a solid understanding of the entire clinical trials process, as well as a foundation in the scientific principles, regulations, and ethics that are vitally important to the conduct of clinical research.
More »

San Francisco State University ExtensionThrough the Clinical Trial Design and Management Certificate Program students may complete a full certificate or simply take those courses which advance their own professional goals. The program is designed to be flexible for working adults by offering evening or weekend courses. More »

University of California Berkeley ExtensionUC Berkeley Extension offers a Certificate Program in Clinical Research Conduct and Management which enables you to master practical aspects of clinical trial conduct and management, including clinical trial phases and design, planning, implementation, data analysis, regulatory and procedural guidelines, and ethical considerations.
More »

Key Points

Some of this training is required before any research participants can be enrolled in a clinical study.

You are responsible for maintaining training compliance for yourself, and if you are a PI, that of your research team.

RECOMMENDED TRAINING

eProtocol TrainingeProtocol is an online application used at Stanford to submit, review, and approve research (human subjects; stem cells; animal subjects; and biosafety). More »

GCP Training through CITI
If you are new to research or just need a refresher course, Good Clinical Practice (GCP) guidelines are available on-line through the IRB’s CITI training. More »

Budgeting and Billing Training
Required for all new and current employees who work on clinical research projects, if involved in budgeting and billing. Spectrum OTC offers monthly training sessions.
More »

Orientation to Clinical Research at Stanford (General Orientation)
Required for new employees who are working in clinical research. At this orientation Spectrum OTC staff will meet with clinical research personnel to provide resources and tools to successfully navigate research studies at Stanford. More »

EDUCATION / WORKSHOPS

ICCR – Intensive Course in Clinical Research: Study Design and Performance
The Intensive Course in Clinical Research (ICCR) is a one-week immersion course developed at Stanford for new clinical investigators, senior residents, fellows and junior faculty, interested in pursuing careers in clinical and translational research. More »

Find a Workshop
View upcoming CTR educational workshops offered by Spectrum and affiliates, past presentations and videos, a list of courses, or request a workshop. More »

Request a Workshop
View list of workshop topics, or suggest a topic. More »

OTHER TRAINING RESOURCES – STANFORD

Spectrum Child Health

Pediatrics Mentoring Program
The Pediatrics Mentoring Program is dedicated to the academic enrichment and success of early career investigators in the Department of Pediatrics. More »

ICCR – Intensive Course in Clinical Research: Study Design and Performance
The Intensive Course in Clinical Research (ICCR) is a one-week immersion course developed at Stanford for new clinical investigators, senior residents, fellows and junior faculty, interested in pursuing careers in clinical and translational research. More »

Epic Training
Epic Training is required for all Stanford Hospital and Clinics physicians and medical personnel who need access to Hospital Medical Records.
Training is completed online. The specific courses that you are required to complete are dependent on your specialty, sub-specialty and scope of clinical practice. More »

Cancer Clinical Trials Office (CCTO)The CCTO provides training and quality assurance programs for both new and existing research staff to ensure that Cancer Institute research staff are current on all regulatory requirements as well as SCI standard operating procedures. More »

Tech Training
Stanford University Information Technology Services (ITS) provides technology courses. See the ITS website for training options in the classroom, online, one-on-one by appointment, and custom classes. More »

STARS
The Stanford Training And Registration System (STARS) is Stanford's Learning Management System. Log in to Axess to see the STARS Training website which includes a “STARS Browse Catalog” and a “Training Needs Assessment” tool. More »

Learning and Organizational Effectiveness
LOE Calendar of Course, Programs, and Conferences. More »

Office of Sponsored Research (OSR)
The OSR website provides a list of recommended classes for those working with sponsored research. More »

PROFESSIONAL DEVELOPMENT RESOURCES – NON-STANFORD

ACRP
ACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings. More »

University of California Santa Cruz, Extension
The UCSC Extension Certificate in Clinical Trials Design and Management is designed to help professionals gain a solid understanding of the entire clinical trials process, as well as a foundation in the scientific principles, regulations, and ethics that are vitally important to the conduct of clinical research.
More »

San Francisco State University ExtensionThrough the Clinical Trial Design and Management Certificate Program students may complete a full certificate or simply take those courses which advance their own professional goals. The program is designed to be flexible for working adults by offering evening or weekend courses. More »

University of California Berkeley ExtensionUC Berkeley Extension offers a Certificate Program in Clinical Research Conduct and Management which enables you to master practical aspects of clinical trial conduct and management, including clinical trial phases and design, planning, implementation, data analysis, regulatory and procedural guidelines, and ethical considerations.
More »

Key Points

Some of this training is required before any research participants can be enrolled in a clinical study.

Most training required for postdocs is managed by your department administrator

Spectrum OTC provides education, required training and professional growth opportunities to the Stanford clinical research community.

Whether new to Stanford or in need of a refresher course, the below list of training programs provides the information necessary to successfully conduct clinical research at Stanford.

REQUIRED TRAINING FOR CLINICAL RESEARCH FACULTY

Collaborative IRB Training Initiative (CITI)* (Required)
Required human subjects training for all staff who work on research projects (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting). More »

Environmental Health and Safety Training AssessmentEveryone in the Stanford community is required to take some safety training. To clarify what safety training is necessary for each job function, Environmental Health and Safety developed the Training Assessment online tool for determining what safety training a SU employee needs to take. More »

HIPAA Training
Stanford HIPAA training is required for every member of the workforce who comes into contact with Protected Health Information (PHI). More »

Training for Sponsor Investigator Research (SIR)Required for investigators who intend to obtain their own Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications from FDA. More »

RECOMMENDED TRAINING

eProtocol TrainingeProtocol is an online application used at Stanford to submit, review, and approve research (human subjects; stem cells; animal subjects; and biosafety). More »

GCP Training through CITI
If you are new to research or just need a refresher course, Good Clinical Practice (GCP) guidelines are available on-line through the IRB’s CITI training. More »

Budgeting and Billing Training
Required for all new and current employees who work on clinical research projects, if involved in budgeting and billing. Spectrum OTC offers monthly training sessions. More »

Orientation to Clinical Research at Stanford (General Orientation)
Required for new employees who are working in clinical research. At this orientation Spectrum OTC staff will meet with clinical research personnel to provide resources and tools to successfully navigate research studies at Stanford. More »

EDUCATION / WORKSHOPS

ICCR – Intensive Course in Clinical Research: Study Design and Performance
The Intensive Course in Clinical Research (ICCR) is a one-week immersion course developed at Stanford for new clinical investigators, senior residents, fellows and junior faculty, interested in pursuing careers in clinical and translational research. More »

Find a Workshop
View upcoming CTR educational workshops offered by Spectrum and affiliates, past presentations and videos, a list of courses, or request a workshop. More »

MENTORING

Mentoring Support for Junior Investigators
Child Health junior investigators can participate in the mentoring program conducted by Spectrum Child Health. Expansion of this program for additional investigators is underway. More »

OTHER TRAINING RESOURCES – STANFORD

Spectrum Child HealthSpectrum Child Health offers a centralized clinical core with research support personnel, assistance with scientific expertise and advice, and career development training for junior investigators. More »

Epic Training
Epic Training is required for all Stanford Hospital and Clinics physicians and medical personnel who need access to Hospital Medical Records.
Training is completed online. The specific courses that you are required to complete are dependent on your specialty, sub-specialty and scope of clinical practice. More »

Tech Training
Stanford University Information Technology Services (ITS) provides technology courses. See the ITS website for training options in the classroom, online, one-on-one by appointment, and custom classes. More »

STARS
The Stanford Training And Registration System (STARS) is Stanford's Learning Management System. Log in to Axess to see the STARS Training website which includes a “STARS Browse Catalog” and a “Training Needs Assessment” tool. More »

Learning and Development
Information and awareness of resources for courses, programs, and conferences useful to any staff member for professional development. More »

Leadership Training
The Office of Diversity and Leadership provides several programs that enable faculty to build and develop leadership skills. More »

Office of Sponsored Research (OSR)
Provides pre- and post-award administration of sponsored projects to the University. More »

PROFESSIONAL DEVELOPMENT RESOURCES – NON-STANFORD

ACRP
ACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings. More »

University of California Santa Cruz, Extension
The UCSC Extension Certificate in Clinical Trials Design and Management is designed to help professionals gain a solid understanding of the entire clinical trials process, as well as a foundation in the scientific principles, regulations, and ethics that are vitally important to the conduct of clinical research.
More »

San Francisco State University ExtensionThrough the Clinical Trial Design and Management Certificate Program students may complete a full certificate or simply take those courses which advance their own professional goals. The program is designed to be flexible for working adults by offering evening or weekend courses. More »

University of California Berkeley ExtensionUC Berkeley Extension offers a Certificate Program in Clinical Research Conduct and Management which enables you to master practical aspects of clinical trial conduct and management, including clinical trial phases and design, planning, implementation, data analysis, regulatory and procedural guidelines, and ethical considerations.
More »

Key Points

Some of this training is required before any research participants can be enrolled in a clinical study.

You are responsible for maintaining training compliance for yourself, and if you are a PI, that of your research team.

Budgeting and Billing Training is required for all new and current employees working on clinical research projects, if involved in budgeting and billing (i.e. research coordinators enrolling study participants).

Training provides a general overview of the clinical research budgeting and billing process. It includes the Budgeting and Billing workbook process; billing procedures; and a review of the Medicare NCD policy.

This 2-hour training is offered monthly. Special training sessions are available for groups or departments upon request.

Key Points

Recommended for all research personnel who enroll study participants.

Next Steps

Register for Training
Register for training on STARS. If you do not have a SUnet ID, contact Education and Training Coordinator.

The goal of the Cardinal Curriculum is to develop Stanford's research administration workforce by providing tools for individuals to build competencies, increase efficiency, and improve compliance with Stanford and sponsor requirements. The certification program ensures a standard level of expertise among those who support the research endeavor at Stanford University.

Cardinal Curriculum training classes, which can lead to certification, are organized into two levels and are geared to individuals as they develop from novice to expert in research administration. Level I classes should be completed before attempting Level II classes. The ORA Training and Development Office tracks and awards certification.

Who can benefit from these classes?

Research administrators and all administrative staff who support sponsored research including:

individuals involved with proposal preparation

individuals who originate or approve transactions on sponsored accounts

individuals who review or monitor expenditures on sponsored projects.

If you have questions, email or phone Lisa Teresi-Forgatsch, Office of Research Administration, at 725-9830.

Next Steps

More Information
Level I and II Classes and Certification
Register for Cardinal Curriculum Certification Programs and Classes
Detailed Instructions for Registration

The Orientation to Conducting Clinical Research at Stanford (CTR General Orientation) is a two-hour introduction and review of the clinical research process at Stanford University, designed for new clinical research personnel.

Orientation Objectives:

Provide resources to manage and coordinate clinical research at Stanford University

CITI training is required human subjects training for all staff working on a research project (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting of a research project).

Stanford provides access to the required training through an interactive online tutorial, the Collaborative Institutional Training Initiative (CITI) Course in the Protection of Human Research Subjects.

CITI offers a Basic (initial) course and then a Refresher course. Training is required every three years (two years for VA).

Key Points

CITI training is required (without exception)

Key personnel is defined in the University Research Policy Handbook.

Next Steps

Register for TrainingThis is the Stanford Research Compliance Office Human Subjects Research Website –Required Tutorial on Human Subject Research Protection. Site includes link to the CITI website to register for training.

Epic Training is required for all Stanford Hospital and Clinics physicians and medical personnel who need access to Hospital Medical Records.

To complete the Stanford Hospital and Clinics’ Medical Staff application process, you must complete training for the Epic Clinical Information System. Training is completed online. The specific courses that you are required to complete are dependent on your specialty, sub-specialty and scope of clinical practice.

LPCH applicants: You may not require Epic training as LPCH is on a different electronic medical record system. If your specialty, sub-specialty and scope of clinical practice indicate that you may require access to Epic, you will have training assigned.

Key Points

Epic Training is required for all SHC physicians and medical staff who need access to hospital medical records.

Epic Training may be required of LPCH physicians and medical staff whose specialty, sub-specialty and scope of clinical practice indicate that access to Epic may be needed.

Next Steps

The National Institutes of Health, through its Office of Clinical Research Training and Medical Education, offers several courses for online training in the area of clinical research.

Introduction to the Principles and Practice of Clinical Research

This is a course on how to effectively conduct clinical research, formalizing instruction that is normally taught through mentorship. The recommended textbook is Principles and Practice of Clinical Research, second edition (2007), edited by John I. Gallin and Frederick P. Ognibene and published by Academic Press/Elsevier (Lane Library | Amazon).» Course information and application.

Principles of Clinical Pharmacology

This course consists of a weekly lecture series covering the fundamentals of clinical pharmacology as a translational scientific discipline focused on rational drug development and utilization in therapeutics. The recommended textbook is Principles of Clinical Pharmacology, Second Edition (2007) edited by Arthur J. Atkinson, Jr., et al. and published by Academic Press/Elsevier (Amazon). This complements the material covered in the “Introduction to the Principles and Practice of Clinical Research.”

This course was designed to assist individuals who are preparing to take the certifying examinations of the American Board of Clinical Pharmacology and to meet the needs of researchers with an interest in the clinical pharmacologic aspects of contemporary drug development and utilization.» Course information and application.

Clinical Research Training Online Course for Principal Investigators

This course addresses one of the essential standards approved by the NIH for performing clinical research in the Intramural Research Program. This material is also covered by the "Introduction to the Principles and Practice of Clinical Research" and "Ethical and Regulatory Aspects of Human Subjects Research" courses. » Course information and application.

Next Steps

The Health Insurance Portability and Accountability Act (HIPAA) – Each person at Stanford University who is part of the Stanford University HIPAA Components workforce must be aware of the obligations imposed by HIPAA and the Privacy and Security Rules.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard, published by the International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.

Good Clinical Practice guidelines include the protection of human rights, safety and welfare during clinical trials. They also assure clinical data integrity.

Good Clinical Practice guidelines include standards on how clinical trials should be conducted; and define the roles and responsibilities of clinical trial sponsors, clinical research investigators and monitors.

Good Clinical Practice Fundamentals Course
This one-day course is designed for new clinical research coordinators, nurses and administrative staff, who have limited experience with and no formal training in Good Clinical Practices (GCP). It offers a comprehensive yet concentrated overview of the principles of GCP, FDA and Global Regulations, and the roles and responsibilities of the clinical investigator/site, IRB, sponsor, and study monitor. Emphasis is placed on the translation of GCP principles to the concepts of protocol adherence, informed consent process, good documentation practices, event reporting, and proactive preparation for FDA/Regulatory audits. Interactive exercises and case scenarios facilitate the application of these principles into everyday practice governing the conduct of clinical trials.

GCP Beyond the Basics
For more experienced research coordinators, nurses and staff who are already familiar with basic GCP principles and are looking for more detail in areas of interest, four--hour sessions offer expanded instruction in selected GCP areas such as adverse event reporting, informed consent, and audit readiness.

GCP Brown BagsThe Good Clinical Practice (GCP) Brown Bag sessions are informal monthly meetings open to anyone in the Stanford research community. Brown Bags offer a chance to meet people outside your department, to discuss topics of interest, ask questions and exchange solutions to common challenges. Past sessions have included discussions on working with non-English speakers, consenting participants over the phone and via mail, drug accountability, good documentation, recruitment, research with devices, and more.

Meetings occur on the fourth Thursday of each month from 11:30 – 12:30pm. View the Spectrum Education Calendar for details and topics.

GCP Brown Bag WikiAccessible only to those who have attended a GCP Brown Bag or Course at Stanford. View GCP Brown Bag schedule and best practices, information about upcoming GCP One-day and Beyond the Basics courses.

Boilerplate text describing the FCTR (Freidenrich Center for Translational Research), and the CTRU facilities in the new FCTR space is available for use in your grant proposals. Download this Word document that can be used in your documents (e.g., grant proposals); it can be edited as necessary to fit your needs. Check the date of boilerplate text to ascertain that it is current for your needs.

Next Steps

Boilerplate text describing Spectrum programs and services is available for use in your grant proposals. Several versions, varying in amount of detail, are available in a Word document. Check the date of boilerplate text to ascertain that it is current for your needs.

Next Steps

Good Clinical Practice (GCP) is an international ethical and scientific quality standard, published by the International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.

Good Clinical Practice guidelines include the protection of human rights, safety and welfare during clinical trials. They also assure clinical data integrity.

Good Clinical Practice guidelines include standards on how clinical trials should be conducted; and define the roles and responsibilities of clinical trial sponsors, clinical research investigators and monitors.

Good Clinical Practice Fundamentals Course
This one-day course is designed for new clinical research coordinators, nurses and administrative staff, who have limited experience with and no formal training in Good Clinical Practices (GCP). It offers a comprehensive yet concentrated overview of the principles of GCP, FDA and Global Regulations, and the roles and responsibilities of the clinical investigator/site, IRB, sponsor, and study monitor. Emphasis is placed on the translation of GCP principles to the concepts of protocol adherence, informed consent process, good documentation practices, event reporting, and proactive preparation for FDA/Regulatory audits. Interactive exercises and case scenarios facilitate the application of these principles into everyday practice governing the conduct of clinical trials.

GCP Beyond the Basics
For more experienced research coordinators, nurses and staff who are already familiar with basic GCP principles and are looking for more detail in areas of interest, four--hour sessions offer expanded instruction in selected GCP areas such as adverse event reporting, informed consent, and audit readiness.

GCP Brown BagsThe Good Clinical Practice (GCP) Brown Bag sessions are informal monthly meetings open to anyone in the Stanford research community. Brown Bags offer a chance to meet people outside your department, to discuss topics of interest, ask questions and exchange solutions to common challenges. Past sessions have included discussions on working with non-English speakers, consenting participants over the phone and via mail, drug accountability, good documentation, recruitment, research with devices, and more.

Meetings occur on the fourth Thursday of each month from 11:30 – 12:30pm. View the Spectrum Education Calendar for details and topics.

GCP Brown Bag WikiAccessible only to those who have attended a GCP Brown Bag or Course at Stanford. View GCP Brown Bag schedule and best practices, information about upcoming GCP One-day and Beyond the Basics courses.

The roles and responsibilities of School of Medicine organizational units, institutional officials and key individuals in the areas of grant compliance and institutional oversight are summarized below.

The Research Process Managers (RPMs) in RMG are the primary point of contact for sponsors and Department/Institute grant and contract administrators.
RPMs are the University’s sponsored projects institutional representatives for School of Medicine faculty.
RPMs are assigned to each division in the Department of Medicine and School of Medicine Institutes. » RPM Assignments

Partnering with faculty and staff, RPMs

direct and manage the proposal process to ensure timely, compliant and accurate submissions

develop budgets for all proposals with the PI

accept and negotiate grant awards on behalf of the University

provide expert consultation and oversight to ensure that sponsored research funds are managed and expended in compliance with internal and external policies

continue as the institutional representative throughout the life of the award

Office of Sponsored Research (OSR) Accounting

OSR Accounting performs post award activities, including

account set-up review, billing, and reviewing cost transfers for compliance with University and sponsor policies

preparation of interim and final reports for various University sponsors

Parallel Processing (PP) is the process that supports simultaneous budget development and negotiation, contract negotiation, and IRB review in order to expedite commencement of a study.

RMG will coordinate with the OSR contract office once they receive documents (study protocol, etc.) for a new study from the IRB or the PI. This allows RMG, OSR, and the IRB to begin their review and negotiation processes in parallel, rather than sequentially.

PI and/or Study Coordinator

Forwards sponsor payment schedule and contact information to RMG.

Downloads and completes CTRP Workbook, available on the Spectrum website through Study Navigator, separating standard of care (covered by insurance) versus research costs (paid by the sponsor and included in the study budget).

Supplies contact information and draft contract to OSR.

RMG

Establishes initial institutional record for the study and tracks its status until awarded.

Sends acknowledgement to PI of receipt of study information/application and notifies PI of missing requirements needed to commence budgeting; acknowledgment will also provide the name of the CT RPM who will work with the PI, and the SPO #, the unique institutional designation for every sponsored project.

TRAM, the Translational Research and Applied Medicine Program, is dedicated to fostering interactions between physicians and scientists that translate bench-side discoveries into the clinic.

It was established to provide an infrastructure to rapidly translate novel genomic/proteomic, nanoscale and imaging research discoveries from the laboratory to the clinic and facilitate bench-to-bedside development of cellular therapies.

TRAM helps to support diverse translational research projects that will result in innovative approaches to the prevention, early detection, diagnosis and treatment of human cancers, heart disease, HIV infection, myelofibrosis, systemic sclerosis, graft-versus-host, as well as other human diseases.

Have Questions?

Contact us to learn more about clinical trials or conducting medical research at Stanford University.

Contact Spectrum

Telephone: (650) 498-6498

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Spectrum is part of the Clinical and Translational Science Award (CTSA) program, funded by the National Center for Advancing Translational Sciences (Grant: UL1 TR001085) at the National Institutes of Health (NIH). All publications resulting from the use of Spectrum resources must cite this grant number.